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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, secondary
510(k) Number K050231
Device Name ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis,  IN  46250
Original Contact kay a taylor
Regulation Number862.1150
Classification Product Code
JIT  
Subsequent Product Code
NIG  
Date Received01/26/2005
Decision Date 07/06/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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